Managing the Complexities of Global Pharmaceutical Sourcing
Sponsored By: DPT Laboratories
With the increased globalization and complexity of the pharmaceutical supply chain, managing the sourcing of materials has become extremely challenging. Reducing time and costs are important goals of sourcing, but increased regulations and more rigorous enforcement make these goals difficult to achieve. These trends have forced life science industry companies to optimize sourcing activities for raw materials, intermediates, active pharmaceutical ingredients (APIs), and other material components for clinical supplies and commercial manufacturing. Download this white paper to learn more.

Genetic Assessment of Microbial Diversity in Four Geographically Separated Manufacturing Facilities in the United States
Sponsored By: Charles River
In this study, Charles River highlights the importance of environmental monitoring in trending and tracking and the awareness that each facility has its own microbial niche that contributes to product and process contamination.

Melt Extrusion – Shaping Dosage Forms in the 21st Century
Authors: Charlie Martin; Feng Zhang, PhD; James C. DiNunzio, PhD
Sponsored By: Leistritz
Melt extrusion has been an established industrial manufacturing technology for more than 50 years. It is only in the last decade or so that it has emerged as a viable platform for pharmaceutical development. Today, applications of melt extrusion range from controlled release systems to oral bioavailability enhancement and show potential for small molecules and therapeutic peptides.

Implementing Disposable Cleanroom Apparel into the Manufacturing Process
Author: Damon Larking
Sponsored By: Kimberly-Clark Professional
This paper addresses the benefits of disposable cleanroom apparel versus reusable apparel. It explains how disposable cleanroom apparel can help play a role in helping pharmaceutical manufacturers reduce their waste stream while reducing the risk of contamination.

Examining the Role of TOC Analyzers in the Pharmaceutical Laboratory
Sponsored By: Shimadzu Scientific Instruments
Within the pharmaceutical industry, TOC analyzers serve vital roles in the manufacturing process, from inspections of the water used in drug manufacture (ultrapure water) to evaluation of cleaning effectiveness (cleaning validation). This paper examines their use and presents some application data.

Analysis for Polysorbate 80 Using New High Performance Liquid Chromatography (HPLC) Method with Charged Aerosol Detection (CAD)
Author: Lindsay L. McNalley
Sponsored By: Impact Analytical
Polysorbate 80 (polyoxyethylene (20) sorbitan monooleate) is a common nonionic surfactant, emulsifier and solubilizer that is used in a wide variety of industries and applications. Polysorbate 80 is typically used in food products, cosmetics, medications, vitamins, and vaccines. There can be many reasons a company may need to determine the exact amount of polysorbates in their material. For example, companies may need to determine AIG limits in their products, validate analytical methods for product production, or require the information for reverse engineering purposes. Thus, a well-developed analytical method is crucial for accurately quantitating polysorbates.